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Recommended Principles to Guide Academy-Industry Relationships PDF

370 Pages·2013·4.77 MB·English
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Recommended Principles to Guide Academy-Industry Relationships Purpose: To sustain and protect academic freedom, academic professionalism, research integrity, and public trust. Dedicated to the memory of Victor J. Stone (AAUP President, 1982–84), University of Illinois College of Law AmericAn AssociAtion of University Professors Distributed by the University of Illinois Press To impart the results of their own and their fellow specialists’ investigations and reflection, both to students and to the general public, without fear or favor . . . requires (among other things) that the university teacher shall be exempt from any pecuniary motive or inducement to hold, or to express, any conclusion which is not the genuine and uncolored product of his own study or that of fellow specialists. Indeed, the proper fulfillment of the work of the professoriate requires that our universities shall be so free that no fair- minded person shall find any excuse for even a suspicion that the utterances of university teachers are shaped or restricted by the judgment, not of profes- sional scholars, but of inexpert and possibly not wholly disinterested persons outside of their own ranks. . . . To the degree that professional scholars, in the formation and promulgation of their opinions, are, or by the character of their tenure appear to be, subject to any motive other than their own sci- entific conscience and a desire for the respect of their fellow experts, to that degree the university teaching profession is corrupted; its proper influence upon public opinion is diminished, and vitiated; and society at large fails to get from its scholars, in an unadulterated form, the peculiar and necessary service which it is the office of the professional scholar to furnish. “1915 Declaration of Principles on Academic Freedom and Academic Tenure,” AAUP Policy Documents and Reports, Tenth Edition (Washington, DC: AAUP, 2006), 294–95. ISBN 978-0-252-03824-2 (hardcover) ISBN 978-0-252-07982-5 (paperback) ISBN 978-0-252-09658-7 (eBook) © copyright 2014 by the AAUP foundation Washington, Dc This report was largely written prior to the 2013 organizational restructuring of the American Association of University Professors, but it is being published in book form by the AAUP Foundation, a legal entity that was established through the restructuring. The AAUP Foundation was organized for such charitable and educational purposes, including establishing and supporting principles of academic freedom and the quality of higher education in a free and democratic society. C ontents Preface .......................................................................v Glossary of acronyms and abbreviations .......ix summary of recommendations ............................1 introduction .........................................................25 • Why the AAUP Is Issuing This Report ............................................25 • Academic Freedom: The Relationship between Individual Faculty Rights and the Public Interest .........................................................29 • Embracing Diverse Missions: A Brief History of Academy- Industry Relationships ....................................................................35 • The Growth of University-Industry Engagement: 1970 to the Present .........................................................................39 • What Accounts for Rising Levels of Academy- Industry Engagement? ....................................................................47 The Bayh-Dole Act, the Stanford v. Roche Decision, and Campus IP Management ......................................................47 Other Factors Driving Academy-Industry Engagement ...............63 • Types of Academy-Industry Research Collaboration ........................65 • The Benefits and Compromises of Academy- Industry Engagement ......................................................................68 • Six Risks of Academy-Industry Engagement ....................................71 Risk 1: Violations of Academic Freedom and Researcher Autonomy ..................................................................................71 Risk 2: Restricted Access to Data and Suppression of Negative Results .........................................................................83 Risk 3: Threats to Open Science, Knowledge Sharing, and Timely Publication .....................................................................89 Risk 4: Financial Conflicts of Interest (FCOI) .............................95 Risk 5: Research Bias and Unreliability Associated with Corporate Funding ..........................................101 Risk 6: The Absence of Legal Protections to Safeguard Research Integrity and Academic Freedom in Industry- Sponsored Research Contracts ..................................................112 detailed discussion of the 56 recommended PrinciPles .................. 117 • Part i. General Principles to Guide Academy-Industry Relationships University-Wide (1–7) ............................................118 • Part ii. General Principles for Academic Education and Training (8–10) .............................................................................136 • Part iii. General Principles for Management of Intellectual Property (IP) (11–21) ....................................................................141 • Part iv. General Principles for Management of Conflicts of Interest (COI) and Financial Conflicts of Interest (FCOI) (22–31) .........................................................................................163 • Part v. Targeted Principles: Managing COI in the Context of Clinical Care and Human Subject Research (32–35) .................189 • Part vi. Targeted Principles: Strategic Corporate Alliances (SCAs) (36–48) .............................................................................194 • Part vii. Targeted Principles: Clinical Medicine, Clinical Research, and Industry Sponsorship (49–56) .................................213 aPPendiX a: faculty handbook and collective barGaininG aGreement versions of the 56 PrinciPles ............................ 230 aPPendiX b: the sources of the 56 PrinciPles: a summary of Which PrinciPles are neW, versus those derived from aauP or other Professional GrouPs’ recommendations ....... 247 endnotes ................................................................ 269 Preface T he American Association of University Professors (AAUP) hereby issues this comprehensive report, Recommended Principles to Guide Academy-Industry Relationships. Work on this project began prior to the 2013 organizational restructuring of the AAUP and at that time was funded by a bequest from the estate of Victor J. Stone, a professor in the College of Law at the University of Illinois at Urbana-Champaign who served as AAUP general counsel and from 1982 until 1984 as AAUP president, and by grants from the Open Society Foundations, the AAUP’s Academic Freedom Fund, and the Canadian Association of University Teachers (CAUT). This report is being published in book form by the AAUP Foundation, which was established through restructuring to support academic freedom and the quality of higher education in a free and democratic society. Grants to the AAUP (before restructuring) and to the AAUP Foundation (after restructuring) from a number of AAUP chapters and state conferences have made the publication of this book possible. Donors include the chapters at Connecticut State University, Michigan State University, Oakland University, the University of New Hampshire, the University of Rhode Island, Rider University, the University of Illinois at Urbana-Champaign, Utah Valley University, and Wright State University, as well as the Assembly of State Conferences, the Nevada Faculty Alliance, and the AAUP state conferences in Alabama, California, Colorado, Connecticut, Illinois, Louisiana, Minnesota, Missouri, New York, Ohio, Texas, and Washington. An updated list of donors will be published in Academe. This is perhaps the longest report the AAUP has ever produced, as well as the most comprehensive in its scope and collation of empirical evidence. It addresses issues that make the news weekly and regularly affect higher education in the United States and across the world. The days when industry- funded research was concentrated in a limited number of universities have v vi PREFACE passed. Every type and size of institution now faces both the opportunities and the responsibilities associated with industry-sponsored research relation- ships. And such relationships occur throughout the world. As a result, faculty members both here and abroad should find the report useful. In the Summary of Recommendations, the report first outlines the 56 principles that the AAUP recommends all colleges and universities adopt, as appropriate, in their governing and advisory documents to manage academy- industry engagement. Appendix A provides condensed versions of the 56 principles in language suitable for faculty handbooks and collective bargain- ing agreements. The precise language a campus chooses to employ might vary according to the nature of the destination document, but much of the sample policy language provided in Appendix A should prove directly transferable. The lengthy Introduction to this report provides a detailed overview of the current state of engagement between industry and the academy, and discusses why the AAUP is issuing these 56 principles now. The main body of the report analyses each of the AAUP’s 56 recommended principles individu- ally, discussing its rationale, significance, and application in detail. A faculty senate involved in reviewing, adopting, and implementing the recommenda- tions should benefit from this detailed information. Finally, Appendix B summarizes the provenance and specific sources for each of the 56 principles, identifying whether each is drawn directly from previous recommendations issued by the AAUP and other professional asso- ciations, or whether it is new. The report demonstrates the urgent need to give faculty governing bod- ies greater authority over the principles and practices that regulate outside funding, and over the disposition of inventions derived from faculty research. But the report is by no means exclusively an assertion of faculty rights. It specifies—and emphasizes—the responsibilities that must come with outside funding, including public disclosure of financial conflicts of interest. Not all will readily embrace these responsibilities, but the time has surely come when every institution must debate and consider them. This report began with a 2010 decision by Committee A on Academic Freedom and Tenure to examine the issues surrounding industry-academy engagement. A small group met early in 2011 to draft a set of sample recom- mendations. The resulting discussion began to reveal the scope and challenges of the project. Jennifer Washburn, an investigative journalist and author familiar with the relevant literature, was invited to help prepare a full report in collaboration with AAUP president Cary Nelson. Valuable advice came from Ernst Benjamin, former AAUP general secretary, Cat Warren, editor of Academe, and from the AAUP’s Department of Academic Freedom, Tenure, and Shared Governance. A draft was then sent for review and comment to PREFACE vii three AAUP standing committees (Academic Freedom and Tenure, College and University Governance, and Professional Ethics—chaired at the time, respectively, by David Rabban, Larry Gerber, and Debra Nails) and to numer- ous knowledgeable faculty members, administrators, and other authorities. A substantial packet of responses included comments from Marcia Angell (Medicine, Harvard University), Gerald Barnett (Research Technologies Enterprise Initiative), Eric Campbell (Medicine, Harvard University), Michael Davis (Philosophy, Illinois Institute of Technology), John R. Fuisz (The Fuisz-Kundu Group LLP), Larry Gerber (History, Auburn University), Gregory Girolami (Chemistry, University of Illinois at Urbana-Champaign), Stanton A. Glantz (Medicine, University of California, San Francisco), Robert Gorman (Law, University of Pennsylvania), Claire Katz (Philosophy, Texas A&M University), Jonathan Knight (former head of the AAUP Department of Academic Freedom, Tenure, and Shared Governance), Sheldon Krimsky (Urban and Environmental Policy, Tufts University), Russ Lea (Vice President for Research, University of South Alabama), Risa Lieberwitz (Labor and Employment Law, Cornell University), Gerald Markowitz (Public Health and American Social History, John Jay College of Justice), Debra Nails (Philosophy, Michigan State University), Richard Nelson (International Political Economy, Columbia University), Christopher Newfield (English, University of California, Santa Barbara), David Rosner (History and Public Health, Columbia University), Donald Stein (Medicine, Emory University), Joerg Tiede (Computer Science, Illinois Wesleyan University), Paula A. Treichler (Communications Research and Medicine, University of Illinois at Urbana-Champaign), John Wilson (editor of Illinois Academe), and Stephen Wing (Epidemiology, North Carolina State University). Washburn and Nelson incorporated the responses as appropriate into a revised draft for the standing committees to review. The consultant readers are not, of course, responsible for the final recommendations, and providing their names here does not imply their endorsement of all our recommendations, but thanks go to them for their serious, detailed, and immensely helpful engagement with the text. A draft of the report was published online for comment in June 2012. Among the additional responses received at that point was a detailed com- mentary from the Association of University Technology Managers (AUTM). Once again, the coauthors of the report, Washburn and Nelson, incorporated appropriate comments into a revised version of the report. Final responsibil- ity for wording and editorial changes, however, rests with Cary Nelson. Jim Turk, the executive director of the Canadian Association of University Teachers, participates in meetings of the AAUP’s Committee A on Academic Freedom and Tenure. CAUT issued a much condensed (and adapted) version viii PREFACE of our Summary of Recommendations at the time we placed our full report online for comment. On a personal note, I would like to give special thanks to Steven Doran, a PhD candidate in Communications at the University of Illinois at Urbana- Champaign, who provided indispensable assistance with the numerous editing, formatting, and computer challenges that accompany a text of this length, and Paula A. Treichler, my lifelong partner, who brought her fearless and unequalled editing skills to the task of polishing the report’s prose. Finally, with a project of this scope, I would like to take the opportunity to recognize the critical help we received from the AAUP’s national staff. Greg Scholtz helped us manage the approval process and our requests from the Academic Freedom Fund. Bob Kreiser, possessing wide knowledge of AAUP history and principles, pointed us toward key documents and gave sage advice about the 56 recommended principles. Mike Ferguson found a copy editor, design- er, and printer and managed their work while also obtaining cost estimates for the project. Ezra Deutsch-Feldman shepherded us through several chal- lenges handling such a complex electronic document. Robin Burns shared the public comment version of the report with reporters, while Katherine Isaac distributed it to faculty members nationwide. Finally, I would like to thank Martin Snyder, who helped to manage this massive enterprise with flawless political and practical wisdom at every stage of the process. Income from the sale of this book is divided equally between the University of Illinois Press and the AAUP Foundation. Cary Nelson AAUP President, 2006–12 Glossary of Acronyms and Abbreviations AAMC—Association of Academic Medical Centers AAMC—Association of American Medical Colleges AAU—American Association of Universities AAUP—American Association of University Professors ABIM—American Board of Internal Medicine ABL—Advanced Biological Laboratory ACE—American Council on Education ACCME—Accreditation Council for Continuing Medical Education ACP—American College of Physicians ADAMHA—Alcohol, Drug Abuse, and Mental Health Administration AGB—Association of Governing Boards AIDS—Acquired Immune Deficiency Syndrome AIR—Academy-Industry Relationship AMSA—American Medical Student Association APA—American Psychiatric Association ASIM—American Society of Internal Medicine ATS—American Thoracic Society AUTM—Association of University Technology Managers BB&T—Branch Banking and Trust BBC—British Broadcasting Corporation BD—Bayh-Dole Act BIP—Background Intellectual Property BMJ—British Medical Journal CAUT—Canadian Association of University Professors CDC—Centers for Disease Control CFR—Code of Federal Regulations CHE—Chronicle of Higher Education CIA—Central Intelligence Agency CME—Continuing Medical Education CML—chronic myelogenous leukemia COGR—Council on Government Relations COI—Conflict of Interest CRADA—Cooperative Research and Development Agreement DHHS—Department of Health and Human Services DOD—Department of Defense DOE—Department of Energy ix

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ABIM—American Board of Internal Medicine CHE—Chronicle of Higher Education http://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633. pdf ) fostering a significant, if somewhat harder to detect, sea change in the
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Most books are stored in the elastic cloud where traffic is expensive. For this reason, we have a limit on daily download.